Peripheral Vascular DiseasesMSOT_ICNCT05373927
Calf Muscle Perfusion in Patients With Intermittent Claudication by Non-invasive MSOT
An observational study of Peripheral Vascular Diseases and Peripheral Arterial Disease, run by Ulrich Rother at 1 site in Germany.
Trial summary
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on multispectral optoacoustic tomography (MSOT) in a cross-sectional collective of patients with PAD in Fontaine stage II (intermittent claudication) and a healthy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- Multispectral Optoacoustic Tomography (MSOT)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jun 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with * PAD IIa * PAD IIb presenting for consultation during consultation hours of the department of vascular surgery. Healthy volunteers being recruited by notices posted in the clinic with following conditions: * no PAD previously known * no diabetes mellitus previously known * no chronic renal insufficiency previously known * no symptoms of intermittent claudication * ABI with values between 0.9 and 1.4 (screening examination before inclusion in the study) * palpable foot pulses
Who may be able to join
- Patients with manifest PAD in stage II according to Fontaine or categories 1-3 according to Rutherford or healthy volunteers
- Adults (>18 years) who are able to give their consent
Who cannot join
- Patients with PAD stage I, III and IV according to Fontaine or categories 0, 4, 5 and 6 according to Rutherford or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses
- Underage persons
- Lack of written consent
- Safety concerns of the study physician (person with physical, mental or psychiatric conditions which, by the judgement of the study physician, would compromise the person's safety or the quality of the data, thereby rendering the person an ineligible candidate for the study)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
Erlangen, Bavaria, 91054
Ulrich Rother, Dr. med., +4991318542028, ulrich.rother@uk-erlangen.de
Werner Lang, Prof. Dr. med., +4991318532968, werner.lang@uk-erlangen.de
About this study
Official title: Cross-sectional Study of Calf Muscle Perfusion in Patients With Intermittent Claudication by Non-invasive Multispectral Optoacustic Tomography
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on multispectral optoacoustic tomography (MSOT) in a cross-sectional collective of patients with PAD in Fontaine stage II (intermittent claudication) and a healthy control collective (study group 1). The results will be validated using an independent validation group (study group 2).
Read the detailed description
PAD is one of the most common diseases of the elderly. As life expectancy increases, there is a growing need for new treatment concepts and new diagnostic procedures.
Up to now, only the measurement of macrocirculation in the form of CCDS, ABI and measurement of the actual walking distance are available as independent validation measures of revascularization methods (endovascular/open). The S3 guideline for diagnosis, therapy and medical aftercare of PAD published in 2015 by DGA (Deutsche Gesellschaft für Angiologie, German Society for Angiology) recommends such aftercare examinations, especially for patients that underwent vascular surgery. However, for the mentioned validation measures there are some patient groups for which these methods provide only insufficient or unusable results (e.g. diabetes mellitus, terminal renal failure). In these cases, independent verification of the success of the chosen therapy would have to be performed using angiography (digital subtraction angiography, CT angiography or MR angiography). However, this is not routinely performed in the respective patient populations due to the associated risks (including radiation exposure, contrast agent administration, invasiveness).
MSOT provides a new non-invasive diagnostic method that may be able to fill this diagnostic gap. A first study (MSOT_PAD, NCT04641091) confirmed the hypothesis that data collected via MSOT examination of the calf muscle can be used for PAD diagnostics. The derived concentration of oxygenated hemoglobin (HbO2) proved to be the most suitable measurement parameter. A connection could be established between the measured HbO2 concentration and the clinical stage of PAD. Differentiation improved after a standardized exercise of a walking distance of 150 meters, with patients in the stage of intermittent claudication (IC, Fontaine stage II) being more difficult to differentiate in comparison to patients in Fontaine stages III and IV.
The aim of this cross-sectional study is to increase the sensitivity and specificity of the procedure for IC patients by using a more suitable exercise between first and second MSOT measurement, namely repeated heel raises until the occurrence of claudication pain. A subgroup of the IC patients having been included in the study will be asked to undergo the study protocol a second time after interventional/ surgical revascularization. This is to investigate whether and how the improved blood flow situation translates to the measured MSOT parameters.
As additional target variables, the relative, absolute and total walking distance in a 6-minute walk test as well as the PAD-specific quality of life will be recorded with the VASCUQOL-6 questionnaire. A healthy control collective is included as a comparison group.
- Being tested
- Multispectral Optoacoustic Tomography (MSOT)
- Keywords
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Artery Disease, PAD, Intermittent Claudication, Claudicatio intermittens, Critical Limb Ischaemia, CLI, Critical Limb Threatening Ischemia, CTLI, Color-Coded Duplex Sonography, CCDS, Ankle Brachial Index, ABI, Multispectral Optoacoustic Tomography, MSOT, Heel Raises, 6-minute walk test, 6MWT, Muscle Perfusion
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic Tomography (MSOT)Device
Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus triceps surae of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) or one leg in healthy volunteers (total 1 site)
Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / 6-minute walk test (6MWT) / Continued heel raises for at least 30s Receives: Device: Multispectral Optoacoustic Tomography (MSOT) | |
| Study group 2 | Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus triceps surae of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) or one leg in healthy volunteers (total 1 site)
Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / 6-minute walk test (6MWT) / Continued heel raises for at least 30s Receives: Device: Multispectral Optoacoustic Tomography (MSOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal diagnostic MSOT thresholds
Optimal diagnostic threshold for hemoglobin-associated MSOT parameters in calf muscle tissue in patients with intermittent claudication before and after exercise
Measured: single time point (1 day)
Secondary outcomes (15)
Difference between the corresponding MSOT values before and after exercise
Difference of the values before and after exercise for hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT in patients with IC
Measured: single time point (1 day)
Reperfusion profiles for hemoglobin-associated parameters
Curves of hemoglobin-associated MSOT parameters in the first ten minutes after exercise
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with the CCDS flow profile and PSV
Hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) in patients with IC correlated with the flow profile and PSV of A. femoralis communis and A. poplitea determined by CCDS
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with the ABI
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the ABI
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with relative and absolute walking distance
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with relative (until the first occurrence of pain) and absolute walking distance (until the first stopping due to pain) in the 6-minute walk test (6MWT)
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with maximum walking distance within 6 minutes
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the maximum walking distance during the 6 minutes of the 6-minute walk test
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with the subjectively perceived maximum walking distance in everyday life
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the subjectively perceived maximum walking distance in everyday life
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
Measured: single time point (1 day)
Correlation of the acquired MSOT parameters with the TASC-classification (angiography)
Hemoglobin-associated parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT in patients with IC correlated with the TASC-classification (angiography) [If angiographic imaging is already available due to routine diagnostics independently from this study.]
Measured: single time point (1 day)
Subgroup analysis: Difference between the corresponding MSOT values before and after revascularization intervention
Subgroup analysis: Difference of the MSOT values before and after revascularization intervention for hemoglobin-associated parameters derived by transcutaneous MSOT in patients with IC
Measured: two time points (2 days)
Subgroup analysis: Reperfusion profiles for hemoglobin-associated parameters after revascularization intervention
Subgroup analysis: Reperfusion profiles of hemoglobin-associated MSOT parameters (i.e. the curves of hemoglobin-associated MSOT parameters in the first ten minutes after exercise) after revascularization intervention
Measured: single time point (1 day)
Subgroup analysis: Correlation of acquired MSOT parameters after intervention with the CCDS flow profiles and PSVs after intervention
Subgroup analysis: hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT in patients with IC after revascularization intervention correlated with the flow profiles and PSVs of A. femoralis communis and A. poplitea determined by CCDS after revascularization intervention
Measured: single time point (1 day)
Subgroup analysis: Correlation of acquired MSOT parameters after intervention with the ABI after intervention
Subgroup analysis: hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT after revascularization intervention correlated with the ABI measurements after revascularization intervention
Measured: single time point (1 day)
Subgroup analysis: Correlation of acquired MSOT parameters after intervention with relative (until the first occurrence of pain) and absolute walking distance (until the first stopping due to pain) determined during the 6MWT after intervention
Subgroup analysis: hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT after revascularization intervention correlated with relative (until the first occurrence of pain) and absolute walking distance (until the first stopping due to pain) in the 6MWT after revascularization intervention
Measured: single time point (1 day)
Subgroup analysis: Correlation of acquired MSOT parameters after intervention with maximum walking distance in the 6MWT after intervention
Subgroup analysis: hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT after revascularization intervention correlated with the maximum walking distance in the 6MWT after revascularization intervention
Measured: single time point (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start20 Jun 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulrich Rother
- Sponsor type
- University, hospital or other
- Collaborators
- PD Dr. med. Ferdinand Knieling, Department of pediatrics, University of Erlangen-Nürnberg
- Responsible party
- Sponsor-investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373927
- Sponsor's protocol ID
- MSOT_IC
- Acronym
- MSOT_IC
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lawall H, Diehm C, Hoffmann U, Reinecke H. [Update PAVK: Epidemiology, comorbidity and prognosis of peripheral arterial obstructive disease]. Dtsch Med Wochenschr. 2015 Dec;140(24):1798-802. doi: 10.1055/s-0041-107064. Epub 2015 Dec 1. German.
PubMed 26625226Lawall H, Huppert P, Espinola-Klein C, Zemmrich CS, Ruemenapf G. German guideline on the diagnosis and treatment of peripheral artery disease - a comprehensive update 2016. Vasa. 2017 Mar;46(2):79-86. doi: 10.1024/0301-1526/a000603. Epub 2017 Jan 27.
PubMed 28128018Alpert JS, Larsen OA, Lassen NA. Exercise and intermittent claudication. Blood flow in the calf muscle during walking studied by the xenon-133 clearance method. Circulation. 1969 Mar;39(3):353-9. doi: 10.1161/01.cir.39.3.353. No abstract available.
PubMed 4885945Karlas A, Masthoff M, Kallmayer M, Helfen A, Bariotakis M, Fasoula NA, Schafers M, Seidensticker M, Eckstein HH, Ntziachristos V, Wildgruber M. Multispectral optoacoustic tomography of peripheral arterial disease based on muscle hemoglobin gradients-a pilot clinical study. Ann Transl Med. 2021 Jan;9(1):36. doi: 10.21037/atm-20-3321.
PubMed 33553329Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
PubMed 28938901
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study of Calf Muscle Perfusion in Patients With Intermittent Claudication by Non-invasive Multispectral Optoacustic Tomography
- ClinicalTrials.gov ID
- NCT05373927
- Acronym / sponsor ID
- MSOT_IC / MSOT_IC
- Keywords
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Artery Disease, PAD, Intermittent Claudication, Claudicatio intermittens, Critical Limb Ischaemia, CLI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ulrich RotherUniversity, hospital or other
- Collaborators
- PD Dr. med. Ferdinand Knieling, Department of pediatrics, University of Erlangen-Nürnberg
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on multispectral optoacoustic tomography (MSOT) in a cross-sectional collective of patients with PAD in Fontaine stage II (intermittent claudication) and a healthy control collective (study group 1). The results will be validated using an independent validation group (study group 2).
Detailed description
PAD is one of the most common diseases of the elderly. As life expectancy increases, there is a growing need for new treatment concepts and new diagnostic procedures.
Up to now, only the measurement of macrocirculation in the form of CCDS, ABI and measurement of the actual walking distance are available as independent validation measures of revascularization methods (endovascular/open). The S3 guideline for diagnosis, therapy and medical aftercare of PAD published in 2015 by DGA (Deutsche Gesellschaft für Angiologie, German Society for Angiology) recommends such aftercare examinations, especially for patients that underwent vascular surgery. However, for the mentioned validation measures there are some patient groups for which these methods provide only insufficient or unusable results (e.g. diabetes mellitus, terminal renal failure). In these cases, independent verification of the success of the chosen therapy would have to be performed using angiography (digital subtraction angiography, CT angiography or MR angiography). However, this is not routinely performed in the respective patient populations due to the associated risks (including radiation exposure, contrast agent administration, invasiveness).
MSOT provides a new non-invasive diagnostic method that may be able to fill this diagnostic gap. A first study (MSOT_PAD, NCT04641091) confirmed the hypothesis that data collected via MSOT examination of the calf muscle can be used for PAD diagnostics. The derived concentration of oxygenated hemoglobin (HbO2) proved to be the most suitable measurement parameter. A connection could be established between the measured HbO2 concentration and the clinical stage of PAD. Differentiation improved after a standardized exercise of a walking distance of 150 meters, with patients in the stage of intermittent claudication (IC, Fontaine stage II) being more difficult to differentiate in comparison to patients in Fontaine stages III and IV.
The aim of this cross-sectional study is to increase the sensitivity and specificity of the procedure for IC patients by using a more suitable exercise between first and second MSOT measurement, namely repeated heel raises until the occurrence of claudication pain. A subgroup of the IC patients having been included in the study will be asked to undergo the study protocol a second time after interventional/ surgical revascularization. This is to investigate whether and how the improved blood flow situation translates to the measured MSOT parameters.
As additional target variables, the relative, absolute and total walking distance in a 6-minute walk test as well as the PAD-specific quality of life will be recorded with the VASCUQOL-6 questionnaire. A healthy control collective is included as a comparison group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus triceps surae of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) or one leg in healthy volunteers (total 1 site) Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / 6-minute walk test (6MWT) / Continued heel raises for at least 30s |
| Study group 2 | – | Device: Multispectral Optoacoustic Tomography (MSOT)Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus triceps surae of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) or one leg in healthy volunteers (total 1 site) Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / 6-minute walk test (6MWT) / Continued heel raises for at least 30s |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with * PAD IIa * PAD IIb presenting for consultation during consultation hours of the department of vascular surgery. Healthy volunteers being recruited by notices posted in the clinic with following conditions: * no PAD previously known * no diabetes mellitus previously known * no chronic renal insufficiency previously known * no symptoms of intermittent claudication * ABI with values between 0.9 and 1.4 (screening examination before inclusion in the study) * palpable foot pulses
Key inclusion criteria (2 listed)
- Patients with manifest PAD in stage II according to Fontaine or categories 1-3 according to Rutherford or healthy volunteers
- Adults (>18 years) who are able to give their consent
Key exclusion criteria (4 listed)
- Patients with PAD stage I, III and IV according to Fontaine or categories 0, 4, 5 and 6 according to Rutherford or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses
- Underage persons
- Lack of written consent
- Safety concerns of the study physician (person with physical, mental or psychiatric conditions which, by the judgement of the study physician, would compromise the person's safety or the quality of the data, thereby rendering the person an ineligible candidate for the study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacoustic Tomography (MSOT)Non-invasive transcutaneous imaging of subcellular muscle components via infrared and near-infrared laser pulses | Device | Study group 1, Study group 2 |
Primary outcome
Optimal diagnostic MSOT thresholds
Time frame: single time point (1 day)
Optimal diagnostic threshold for hemoglobin-associated MSOT parameters in calf muscle tissue in patients with intermittent claudication before and after exercise
15 secondary outcomes
Difference between the corresponding MSOT values before and after exercise
Time frame: single time point (1 day)
Reperfusion profiles for hemoglobin-associated parameters
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with the CCDS flow profile and PSV
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with the ABI
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with relative and absolute walking distance
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with maximum walking distance within 6 minutes
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with the subjectively perceived maximum walking distance in everyday life
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
Time frame: single time point (1 day)
Correlation of the acquired MSOT parameters with the TASC-classification (angiography)
Time frame: single time point (1 day)
Subgroup analysis: Difference between the corresponding MSOT values before and after revascularization intervention
Time frame: two time points (2 days)
Subgroup analysis: Reperfusion profiles for hemoglobin-associated parameters after revascularization intervention
Time frame: single time point (1 day)
Subgroup analysis: Correlation of acquired MSOT parameters after intervention with the CCDS flow profiles and PSVs after intervention
Time frame: single time point (1 day)
Subgroup analysis: Correlation of acquired MSOT parameters after intervention with the ABI after intervention
Time frame: single time point (1 day)
Subgroup analysis: Correlation of acquired MSOT parameters after intervention with relative (until the first occurrence of pain) and absolute walking distance (until the first stopping due to pain) determined during the 6MWT after intervention
Time frame: single time point (1 day)
Subgroup analysis: Correlation of acquired MSOT parameters after intervention with maximum walking distance in the 6MWT after intervention
Time frame: single time point (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 26625226Lawall H, Diehm C, Hoffmann U, Reinecke H. [Update PAVK: Epidemiology, comorbidity and prognosis of peripheral arterial obstructive disease]. Dtsch Med Wochenschr. 2015 Dec;140(24):1798-802. doi: 10.1055/s-0041-107064. Epub 2015 Dec 1. German.
- Background: PubMed 28128018Lawall H, Huppert P, Espinola-Klein C, Zemmrich CS, Ruemenapf G. German guideline on the diagnosis and treatment of peripheral artery disease - a comprehensive update 2016. Vasa. 2017 Mar;46(2):79-86. doi: 10.1024/0301-1526/a000603. Epub 2017 Jan 27.
- Background: PubMed 4885945Alpert JS, Larsen OA, Lassen NA. Exercise and intermittent claudication. Blood flow in the calf muscle during walking studied by the xenon-133 clearance method. Circulation. 1969 Mar;39(3):353-9. doi: 10.1161/01.cir.39.3.353. No abstract available.
- Background: PubMed 33553329Karlas A, Masthoff M, Kallmayer M, Helfen A, Bariotakis M, Fasoula NA, Schafers M, Seidensticker M, Eckstein HH, Ntziachristos V, Wildgruber M. Multispectral optoacoustic tomography of peripheral arterial disease based on muscle hemoglobin gradients-a pilot clinical study. Ann Transl Med. 2021 Jan;9(1):36. doi: 10.21037/atm-20-3321.
- Background: PubMed 28938901Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases and Peripheral Arterial Disease, run by Ulrich Rother at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Rother, PD Dr. med. (+4991318542028, ulrich.rother@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal diagnostic MSOT thresholds (time frame: single time point (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05373927, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.